Senior R&D Engineer (Strong background in Medical Device Engineering) Onsite

Senior R&D Engineer (Strong background in Medical Device Engineering) Location: San Diego, CA Duration: 6 Months Total Hours/week: 40 Shift: 1st Shift Client: Medical Devices Company Job Category: Engineering Level of Experience: Senior - Level Employment Type: Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT) On site 4 days a week – Travel 10% Job Description We are seeking a highly skilled and experienced R&D Engineer to join our R&D Released Product Management (RPM) team, which supports Alaris infusion products. The ideal candidate will have a strong background in medical device engineering and a deep understanding of industry standards and methodologies. They will wear multiple hats and work with core team members across engineering and project disciplines. Key Responsibilities Conduct root cause analysis and implement corrective actions for product issues. Support product design changes and ensure they meet regulatory and quality standards. Decompose system requirements into subsystem or component specifications. Develop and execute test documentation for verification and compliance testing. Coordinate activities related to product changes with multiple cross‑functional teams, including operations, quality, regulatory, and others. Evaluate risks associated with product changes and provide mitigation strategies. Provide input on reliability, verification, and validation testing. Ensure compliance with ISO 13485, 14971, CFR21, CSA and other relevant regulations and standards. Utilize statistical testing methods and design for manufacturing (DFM) and design for six sigma (DFSS) methodologies. Collaborate with cross‑functional teams to ensure successful product updates and solve complex problems under time‑sensitive deadlines. Maintain thorough documentation of design changes, testing results, and risk assessments. Interact with hardware suppliers to ensure design for manufacturability, testability and overall reliability. Qualifications Bachelor's, Master's or PhD degree in Electrical Engineering or a related field. Minimum 5 years of related experience. Experience with Systems Engineering. Track record of working successfully in a rapidly changing environment with high levels of uncertainty. Strong understanding of ISO 13485, 14971, and other relevant standards. Basic knowledge of PCB and PCBA design. Experience with laboratory tools: oscilloscope, DMM, variable DC power supply, etc. Experience with troubleshooting of electromechanical devices. Basic knowledge of product safety and compliance design and testing. Proven experience with structured problem solving, 8D, CAPA and other problem methodologies. Knowledge of regulatory requirements for medical devices. Experience with risk management and failure mode and effects analysis (FMEA). Experience with statistical testing methods. Excellent problem‑solving skills and the ability to work in a fast‑paced environment. Strong communication and interpersonal skills to effectively collaborate with cross‑functional teams. Ability to manage multiple projects and priorities simultaneously. Proficiency in using engineering tools and software for design and analysis. Preferred Qualifications Master’s or PhD degree in Electrical Engineering or related discipline. Experience with Alaris infusion products or similar medical devices. Certification and experience in design for manufacturing (DFM), design for six sigma (DFSS) methodologies. Critical components and critical parameters management experience. #J-18808-Ljbffr MillenniumSoft Inc